NA 355.89Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982195234), received between Jun 27, 2017 and Sep 12, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN POLYTRAUMA (ACETABULUM, BILATERAL WRISTS, AND TIBIAL NAIL), A FEW PRODUCTS DID NOT WORK. TWO SUPRAPATELLAR HANDLES WERE USED AND UNABLE TO CONNECT THE NAIL. DURING PLACEMENT OF A SACROILIAC SCREW, A LONG EX FIX SLEEVE WAS USED AS A DRILL GUIDE AND THREE WERE BENT. TWO EXTRA LONG VOLAR DISTAL RADIUS PLATES WERE USED AND TWO DISTAL SCREWS DID NOT LOCK IN EACH PLATE. THEY USED A LOCKING TOWER AND SALES REP BELIEVE IT HAD DAMAGED THREADS THAT DAMAGED THE LOCKING MECHANISM INS OF THE PLATE. THEY USED A STANDARD INITIALLY THEN SWITCHED TO NARROW. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203136 ↗
• MalfunctionSep 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN POLYTRAUMA (ACETABULUM, BILATERAL WRISTS, AND TIBIAL NAIL), A FEW PRODUCTS DID NOT WORK. TWO SUPRAPATELLAR HANDLES WERE USED AND UNABLE TO CONNECT THE NAIL. DURING PLACEMENT OF A SACROILIAC SCREW, A LONG EX FIX SLEEVE WAS USED AS A DRILL GUIDE AND THREE WERE BENT. TWO EXTRA LONG VOLAR DISTAL RADIUS PLATES WERE USED AND TWO DISTAL SCREWS DID NOT LOCK IN EACH PLATE. THEY USED A LOCKING TOWER AND SALES REP BELIEVE IT HAD DAMAGED THREADS THAT DAMAGED THE LOCKING MECHANISM INS OF THE PLATE. THEY USED A STANDARD INITIALLY THEN SWITCHED TO NARROW. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202935 ↗
• MalfunctionSep 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN POLYTRAUMA (ACETABULUM, BILATERAL WRISTS, AND TIBIAL NAIL), A FEW PRODUCTS DID NOT WORK. TWO SUPRAPATELLAR HANDLES WERE USED AND UNABLE TO CONNECT THE NAIL. DURING PLACEMENT OF A SACROILIAC SCREW, A LONG EX FIX SLEEVE WAS USED AS A DRILL GUIDE AND THREE WERE BENT. TWO EXTRA LONG VOLAR DISTAL RADIUS PLATES WERE USED AND TWO DISTAL SCREWS DID NOT LOCK IN EACH PLATE. THEY USED A LOCKING TOWER AND SALES REP BELIEVE IT HAD DAMAGED THREADS THAT DAMAGED THE LOCKING MECHANISM INS OF THE PLATE. THEY USED A STANDARD INITIALLY THEN SWITCHED TO NARROW. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202855 ↗
• MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN INSERTING SCHANZ PIN, OUTER PROTECTION SLEEVE GOT STUCK AND WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. PATIENT WAS NOT AFFECTED. THIS REPORT INVOLVES ONE (1) 6.0MM/5.0MM DRILL SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922229 ↗
• MalfunctionJun 27, 2017Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING, A SMALL PIECE ON THE END OF THE DRILL SLEEVE IS DISCOVERED BENT/BROKEN. SALES CONSULTANT BELIEVES THIS IS DAMAGED FROM WEAR AND TEAR OF USE OF DEVICE. THERE IS NO CASE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.0MM/5.0MM DRILL SLEEVE 98MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6670955 ↗